Reporting undesirable effects

What is an undesirable effect?

Any adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product.

What is a serious undesirable effect (SUE)?

Any undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death.

How to file a report

• The responsible person and the distributors must immediately report serious undesirable effects to the competent authority of the Member State where the serious undesirable effect in question occurred, using Form A , which can be found on the European Commission website.
  
  
• Healthcare professionals and end users (consumers, hairdressers, beauticians, etc.) are encouraged to report any undesirable effect, serious or otherwise, to the ‘Responsible Person’ (manufacturer, importer or designated responsible person) mentioned on the labelling, and/or to the authority of the Member State where the undesirable effect occurred.
  
  For Luxembourg, the undesirable effect report form (Word, 79 Kb) should be duly completed and emailed to: cosmet@ms.etat.lu.
  
  Users are strongly advised to seek medical advice from a healthcare professional, and to keep the suspected cosmetic product(s) for as long as the investigation lasts.